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A Coordinating Center is responsible for overall data management, monitoring and communication among all sites, and general oversight of conduct of the project. A Coordinating Center may be designated either by a sponsor or by mutual agreement of the participating sites.
The JHM IRBs recognize that there are two possible ways for a PI to submit for review protocols describing the Coordinating Center functions when a Hopkins investigator will serve as the PI of a coordinating center:
In either case (1 or 2), the IRB should confirm that the application materials indicate how the following issues are addressed:
Multi-center and multi-site refer to a project that will be conducted at Johns Hopkins and non-Johns Hopkins controlled locations. The JHM IRB defines a multi-center study as a clinical trial that is written to include conduct of a model protocol carried out at more than one medical institution. As part of the application, the investigator shall disclose to the JHM IRB who will serve as the coordinating center for the project.
A multi-site study is defined as a study where the JHM investigator is conducting research at a site(s) not under the control of the Organization. Examples include public elementary schools, nursing homes, health care facilities, private practices, etc. The following information must be provided on the application form for multi-site studies:
IRB staff will check this information on the application.
In order to grant final approval, IRB staff will ensure that:
Final approval will be withheld until the JHM IRB has all required documentation on file.
If any problems arise with external sites, IRB staff will communicate with the contact person named on the application.